Blue Belt Technologies, Inc: Medical Device Recall in 2023 - (Recall #: Z-0041-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299

Product Classification:

Class II

Date Initiated: September 7, 2023

Date Posted: October 11, 2023

Recall Number: Z-0041-2024

Event ID: 93046

Reason for Recall:

CORI software was missing a planning stage that appears in cases of significant knee deformation (outside of the range of 3 degrees valgus to 7 degrees varus) when the surgeon chooses to define the femoral rotational reference via the posterior condylar axis

Status: Ongoing

Product Quantity: 56 units

Code Information:

UDI: (01) 00885556773338 Lot Numbers: 51141585, 51108475, 51108689

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated